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U.S. Department of Health and Human Services

Medical Device Recalls
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Patient Information Center iX and Patient Information Center iX Expand, Software Version 4.x. 2 05/15/2024 Philips North America Llc
The Sophysa Pressio® Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for mon... 2 05/15/2024 Sophysa S.A.
The Sophysa Pressio® Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for mon... 2 05/15/2024 Sophysa S.A.
Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and peripheral veno... 2 05/15/2024 LeMaitre Vascular, Inc.
Ingenia 3.0T with Evolution Upgrade 3.0T - - Magnetic Resonance (MR) systems are Medical Electrical ... 2 05/15/2024 Philips North America Llc
Ingenia 1.5T with Evolution Upgrade 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Sy... 2 05/15/2024 Philips North America Llc
Sterile CoFlex NL: Latex Free Flexible Cohesive Bandage, Tan, 4INx5YD (5400S) 2 05/15/2024 Andover Healthcare Inc.
Novalung sensor box is a component of the Novalung Console (F30000162)-Indicated for long-term (> 6 ... 2 05/15/2024 Fresenius Medical Care Holdings, Inc.
Airvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier, REF: PT100US 2 05/15/2024 Fisher & Paykel Healthcare, Ltd.
APTUS 2.8 TriLock Screw 22mm, HD7, 1/Pkg. Metal bone fixation fastener used with the APTUS fixation ... 2 05/14/2024 Medartis Inc.

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